Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

NCT ID: NCT00487110

Last Updated: 2010-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-06-30

Brief Summary

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A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in healthy volunteers. This study aims at confirming this pharmacodynamic interaction in patients with post-surgery pain.

Detailed Description

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The study is a comparison of the analgesic action of paracetamol versus tropisetron + paracetamol in 30 patients who had surgery of the ear. The evaluation criteria will be the score on the visual analogue scale for pain evaluation.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Tropisetron

a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol

Intervention Type DRUG

paracetamol

a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* More than 18 years
* Men or women
* Ear surgery
* Written consent given

Exclusion Criteria

* Paracetamol hypersensibility
* Tropisetron hypersensibility
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Pickering Gisele, MCU-PH

Role: PRINCIPAL_INVESTIGATOR

Locations

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CHU

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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CHU63-0021

Identifier Type: -

Identifier Source: org_study_id

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